Allergic Rhinitis
Conditions
Keywords
patients, allergic rhinitis, tolerability, safety, nasal symptoms
Brief summary
The primary purpose is to investigate tolerability/safety of repeated weekly doses of AZD8848 administered intranasally to seasonal allergic rhinitis patients.
Interventions
DRUGAZD8848
nasal spray solution; 30 or 60 µg administered intranasally once weekly for one month
DRUGPlacebo
nasal spray solution. Once weekly intranasal administrations for one month.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a history of birch and/ or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years (verified by a positive skin prick test) * Patients with need of treatment for their nasal symptoms during the pollen season
Exclusion criteria
* Clinical relevant disease or abnormality (past or present) - other than allergic rhinitis * Symptomatic perennial allergic or non-allergic rhinitis * A history of asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence/nature of adverse events,pulse, BP, body temperature, ECG parameters, lab assessments | During the study |
| Nasal symptoms, peak nasal inspiratory flow | During the study |
Secondary
| Measure | Time frame |
|---|---|
| Reflective Total Nasal Symptom Score, Peak Nasal Inspiratory Flow | During the study |
| Blood biomarkers and nasal lavage biomarkers | During the study |
| Pharmacokinetics | During the study |
Countries
Sweden
Outcome results
None listed